Pharmacyclics, Inc. announced the publication of positive neurocognitive function and progression results from the company's first randomized Phase 3 clinical trial of its investigational drug Xcytrin (motexafin gadolinium) Injection in combination with whole brain radiation therapy (WBRT) for the treatment of brain metastases in lung cancer patients in the latest issue of the Journal of Clinical Oncology (JCO).
"This is one of the first reports of prospective neurocognitive testing and analyses in patients with brain metastases, and demonstrated that the addition of motexafin gadolinium to whole brain radiation therapy improved time to neurocognitive progression in patients with brain metastases from lung cancer," said Christina Meyers, PhD, lead author of the publication. "Neurocognitive function is a relatively sensitive measure of the functioning of the brain and is predictive of patient outcome."
The study describes detailed findings from neurocognitive testing performed as part of Pharmacyclics' previously published Phase 3, randomized, controlled clinical trial of 401 patients with metastatic cancer to the brain.
Pharmacyclics, together with leading experts in radiation and medical oncology, designed and initiated a pivotal Phase 3 trial known as the SMART (Study of Neurologic Progression with Motexafin Gadolinium And Radiation Therapy) trial. This study is now enrolling patients at leading medical centres in the US, Canada, Europe and Australia. It is designed to compare the effects of WBRT alone to WBRT plus Xcytrin for patients with brain metastases from lung cancer with a primary endpoint of time to neurologic progression as determined by a blinded events-review committee.
In the study reported in JCO, neurocognitive function was measured at baseline prior to therapy and at regular intervals during and after therapy. Neurocognitive function tests evaluated patients' short and long term memory, verbal fluency, decision making and fine motor skills. Over 90 per cent of patients with brain metastases exhibited impairment of one or more neurocognitive tests at baseline.
"This peer reviewed publication establishes that patients with brain metastases have serious neurocognitive impairment, and that Xcytrin may positively impact many of these performance measures, which also are being measured in the SMART trial," said Richard Miller, MD, president and CEO of Pharmacyclics. "Neurologic function, including neurocognitive performance, is a critically important clinical benefit assessment in patients with brain metastases."
Brain metastases is one of the most common conditions treated with radiation therapy. It occurs when cancer cells spread to the brain and grow, causing major neurologic complications and, in most cases, death. Patients with brain metastases usually suffer serious deterioration of neurologic and neurocognitive function such as loss of short-term memory, compromised verbal skills and fine motor coordination, and reduction in cognitive performance. Most patients with brain metastases have multiple lesions and are not candidates for surgical resection or radiosurgery. The goal of whole brain radiation therapy is to reverse or prevent neurological deterioration and prevent death due to tumor progression in the brain.
Pharmacyclics is a pharmaceutical company developing products to improve upon current therapeutic approaches to cancer and atherosclerosis.